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The Gut-Lung Axis and Respiratory Illness in Children

NCT06271213 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-02-21

No results posted yet for this study

Summary

The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.

Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:

* What does a healthy gut-lung axis look like?
* Do children with respiratory issues show an altered gut microbiome?
* Do children with GI issues show an altered lung microbiome?

Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).

Participants will provide:

* airway samples (to investigate the lung microbiome)
* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care
* stool samples (to assess gut microbiome)
* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis.

Conditions

  • Respiration Disorders
  • Respiratory Disease
  • Asthma in Children
  • Wheezing
  • Gastro-Intestinal Disorder
  • Healthy

Interventions

OTHER

observational only - no interventions as part of study

Children with asthma will be receiving biologics therapy as part of their standard of care - unrelated to this study design. All cohorts will be observed without study intervention.

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Ross J Langley, MRCPCH · NHS Greater Glasgow and Clyde Board HQ

Eligibility

Min Age
0 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-04
Primary Completion
2027-11-01
Completion
2028-05-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271213 on ClinicalTrials.gov